Drug product
MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10mL, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0467-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64 vials
- Official record key
drug-enforcement:D-0467-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 10102018@1 BUD: 1/8/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility